A study of a new drug for advanced skin cancer has shown it “almost doubles survival times”, BBC News has reported.
The drug, called vemurafenib, was tested in a clinical trial that examined its impact on tumour size and survival in patients with advanced melanoma skin cancer that had spread to other parts of the body. The outlook for this type of cancer is generally poor as it's an aggressive cancer with few treatment options and patients tend to survive for less than a year. Researchers found that approximately half of the patients responded to the drug and that the overall survival rate in these patients was nearly 16 months, on average.
This study provides evidence on the effectiveness of a new drug, vemurafenib, for treating some patients with metastatic melanoma. Because the drug works by targeting a specific genetic mutation, it won’t be suitable for patients who aren’t carrying the mutation, which is found in around half of patients with melanoma that has spread. Additionally, while the drug has been recommended for approval, it hasn't yet been approved for use in Europe; it is unclear at this point if and when it will be available for treatment in the UK, although the National Institute for Health and Clinical Excellence (NICE is said to be currently assessing it.
Where did the story come from?
The study was carried out by researchers from Vanderbilt University, the Hoffman-La Roche pharmaceutical company and other institutions throughout the US and Australia. The research was supported by Hoffmann-La Roche, who are the manufacturers of vemurafenib.
The study was published in the peer-reviewed New England Journal of Medicine.
The BBC covered this research appropriately, emphasising the positive results but also highlighting that the drug had yet to be approved in the UK and wouldn’t be suitable for all patients with metastatic melanoma. The broadcaster also reported on some of the limitations of the research methods.
What kind of research was this?
This was a phase II clinical trial that examined how effective a drug called vemurafenib was at inducing a clinical response and its impact on overall survival in a set of patients with metastatic melanoma. Malignant melanoma is a relatively rare but aggressive type of skin cancer that can be particularly hard to treat when caught at an advanced stage. All of the patients in the trial carried a specific genetic mutation called the “BRAF V600 mutation”, which leads to the abnormal activation of an enzyme involved in cell growth and death. Previous research indicates that vemurafenib blocks the action of this enzyme.
Phase II trials are designed to assess the effects of new drugs in highly controlled settings. These trials don’t normally employ a group of control patients receiving other forms of treatment, and so generally can’t be used to tell how a new drug compares against standard or existing treatments. These types of control-group comparisons are usually performed in phase III trials. Phase II trials are, however, a key part of the development of new drugs, and are used as a confirmatory step before a drug can be given to wider research populations.
Media coverage of this trial has compared the survival rates of patients receiving vemurafenib with those seen in general patients with metastatic melanoma, rather than patients directly involved in the study. While such comparisons are useful for readers to understand more about the drug, formal scientific comparisons of different treatments have to account for a range of important factors, such as patients’ medical histories or how advanced the cancer is when treatment is started.
What did the research involve?
Researchers enrolled 132 patients with stage IV metastatic melanoma (stage IV cancer means it has spread to other parts of the body, such as the lungs or liver . They all carried a form of BRAF V600 genetic mutation. All patients had previously been treated for the disease, and they all received the same dose of the drug vemurafenib twice a day. The patients stopped taking the drug if they experienced unacceptable side effects or if their disease progressed.
The patients underwent tumour imaging (either magnetic resonance imaging (MRI or computed tomography (CT at the beginning of the study and every six weeks thereafter. Researchers used these scans to assess any changes in tumour size and response to the treatment.
Researchers then analysed the data to determine the proportion of patients who responded to treatment.
What were the basic results?
The patients were followed up for an average (median of 12.9 months. The researchers found that:
- Overall, 53% of patients showed some reduction in the size of their tumour measured at the start of the study.
- Among those that responded, eight patients achieved a complete response (6% of the total study group , and 62 patients (47% achieved a partial response (47% of the total study group .
- Of the patients who responded to treatment, 23 (33% of responders maintained that response at the end of the study.
- The median duration of response was 6.7 months (95% CI 5.6 to 8.6 months .
- Median overall survival was 15.9 months (95% CI 11.6 to 18.3 months , and 62 patients (47% were still alive at the end of the study.
- The overall survival rate at six months was 77% (95% CI 70% to 85% , at twelve months was 58% (95% CI 49% to 67%, and at eighteen months was 43% (95% CI 33% to 53% .
Most patients experienced at least one side effect due to the study drug. The most commonly reported side effects were joint pain, rash, fatigue, sensitivity to light and hair loss. Four patients (3% stopped taking the drug due to side effects. One patient died due to a rapid progression of the melanoma along with kidney failure; the researchers said this may have been related to taking vemurafenib but this was not certain.
How did the researchers interpret the results?
The researchers concluded that vemurafenib effectively targets metastatic melanoma tumours in patients with BRAF V6000 mutations, and that response rates are higher than those seen with other treatments.
Conclusion
This study has shown that patients with a specific mutation and advanced metastatic melanoma have a high response rate to a new drug, vemurafenib. Currently, treatment options for people with metastatic melanoma can involve chemotherapy, radiotherapy or immune therapies, but even with treatment the outlook is usually poor once their cancer has spread. Often, people with late-stage disease may be enrolled in clinical trials such as this to try and find more effective treatments.
Researchers say that the long follow-up of their study provides initial evidence on the overall survival of patients receiving this drug, something that phase III studies have so far not been able to demonstrate.
Researchers point out, however, that patients do develop resistance to vemurafenib, and that further research is needed to determine how this occurs.
Previous studies have shown that patients with metastatic melanoma have an average survival rate of 6 to 10 months, as mentioned in some news coverage. However, it is difficult to compare this estimate to survival times seen in the current study, as the patient populations may be different. For example, it’s unclear whether these studies enrolled patients with the same genetic mutation, or how survival may be different between those with and without the mutation.
This study adds to the mounting evidence of the effectiveness of vemurafenib as a treatment of metastatic melanoma with BRAF V600 mutation. While this phase II study cannot directly demonstrate effectiveness compared to standard care, an additional phase III study has been conducted that randomised patients to receive vemurafenib or standard therapy. This study was stopped before it was complete, as an interim analysis indicated that vemurafenib significantly improved patients' progression-free survival and six-month survival, compared with standard care. At this point, all of the participants were given the new drug.
All in all, this is very promising research for the treatment of an aggressive cancer for which there are few existing options. At present the drug has been recommended for approval by the European Medicines Agency, and is currently being evaluated by NICE for use in the UK.
Analysis by Bazian
Links To The Headlines
Skin cancer drug hopes raised by study. BBC News, February 23 2012
Links To Science
Sosman JA, Kim KB, M.D., Schuchter L et al. Survival in BRAF V600 Mutant Advanced Melanoma Treated with Vemurafenib. New England Journal of Medicine 2012; 366:707-714
UN Population Fund
Burundi
23 Mar 2012
VACANCY NO.: Job ID 1940
CLOSING DATE: 23 March 2012 (5.00 p.m. New York time
POST TITLE: Technical Specialist (MH/RHCS
CATEGORY: ICS-11 (equivalent to P-4
POST NUMBER: New
DUTY STATION: Bujumbura, Burundi
POST TYPE: Non-Rotational
DURATION: One year (renewable 1/
ORGANIZATIONAL UNIT: Burundi Country Office, ARO
BACKGROUND INFORMATION:
Burundi is one the African Countries where maternal morbidity and mortality is a major health concern. According to results of the last DHS and Census, the maternal mortality ratio (MMR was estimated at 866 deaths per 100000 births. In addition, the health system is registering a weak contraceptive prevalence rate (18% and the presence of a skilled attendant at birth is estimated at 60 percent of the deliveries. The HIV prevalence rate remains high (3,58% with a feminization of the infection (4,02% .
Burundi has suffered repeated waves of intense conflict since independence. Thirteen years of ethnically fuelled civil war have weakened the country’s health care system, including the service provision of reproductive health care system, care for victims of sexual violence and HIV/Aids prevention. Also, as a stream 2 country implementing the RHCS Global Program, the CO will be strongly involved into interventions aiming to strengthen the national health system, the health procurement system through advocacy and Policy Dialogue, technical support including monitoring and evaluation, capacity building, management, coordination partnerships development and knowledge sharing on RHCS.
ORGANIZATIONAL SETTING:
The Technical Specialist post is located in the UNFPA Burundi office in Bujumburae. S/he reports to the Representative, who provides overall direction and supervision, and works in close collaboration with the Johannesburg sub-regional office and the Technical Division. The technical Specialist is part of a team and works in an integrated manner with the programme and operation staff. S/he will ensure technical and programmatic support, in accordance with the principles of result based management and good governance to reinforce the quality of the maternal health programme.
DUTIES AND RESPONSIBILITIES:
The Technical Specialist will have the responsibility for health system strengthening and financing for the promotion, design, monitoring and evaluation, equitable access of RH commodity for all sectors, including supply management system. She/he will provide technical advice and support to RH/FP planners, policy makers, programme managers and service providers on national policies and programmes in the field of Reproductive Health. This will include conducting relevant research, analysis and training to improve knowledge sharing. The incumbent will contribute to an enhancement of national capacity to mobilize and obtain social and political support for national policies and programmes in the field of Reproductive Health.
POLICY, ADVOCACY AND RESOURCE MOBILIZATION
• Provide technical assistance to develop the MDG5 component of the United Nations Development Assistance Framework (UNDAF , the UNFPA Country Programme and annual work plans. • Support national implementing partners in advocacy activities for inclusion of RH/RHCS in SWAPs, PRSPs and health sector reforms • Assist and advise the country office in financial resource mobilization for MNH • Advice the country office and national counterparts on integrated approaches to improve reproductive health, in particular to (i Maternal Health, (ii Family planning (including Condom programming • Reinforce and advise staff and national partners on effective supply chain management, including information management, forecasting, distribution and information systems. • Provide technical assistance to national counterparts in the costing and effective implementation of the national reproductive health action plan. • Assist and advice the country to address the urgent need for skilled health workers, particularly midwives • Assist and advise the country to eliminate obstetric fistula • Assist and advise the country to address the financial barriers to access, especially for the poorest • Provide technical assistance to strengthen the national health information system, and monitoring and evaluation.
CAPACITY DEVELOPMENT AND PARTNERSHIPS
• Maintain and foster partnerships with UN agencies and other partners in the technical area of RH, and RHCS for advancement of knowledge. Carry out joint assessments and projects, formulate recommendations on potential critical maternal health issues and provide advice in respect to MDG targets • Provide technical assistance to national partners to scale-up quality health services to ensure universal access to reproductive health, including family planning, skilled attendance at delivery, emergency obstetric and newborn care • Identify, develop and/or adapt training materials and manuals in substantive areas • Strengthen the capacity of national institutions in the areas of needs assessments, resource mobilisation and monitoring and evaluation
EVIDENCE AND KNOWLEDGE DEVELOPMENT AND DISSEMINATION
? Analysis and synthesis trends and research in the area of RHCS and Maternal Health in Cote d’Ivoire to produce technical knowledge ? Advocate for the incorporation of evaluation results and lessons learned in the updating of strategies and approaches in order to improve the effectiveness of UNFPA operations ? Contribute to the successful execution of impact evaluations. Provide support in developing a prioritized operational research agenda for UNFPA ? Promote UNFPA’s comparative substantive role and specific contribution in the changing development agenda
TECHNICAL REPRESENTATION
? Represent UNFPA on substantive issues and support advocacy for RH, and RHCS in international, governmental, U.N., and other policy and technical meetings and seminars ? Collaborate with UN agencies, academia, professional societies, and act as focal point for inter-agency working groups in the substantive area ? Act as the CO’s focal point for RHCS and Maternal Health. Carry out other duties as may be required by UNFPA Representative.
CORE COMPETENCIES:
? Values/Guiding principles; ? Performance management; ? Developing people/Coaching and Mentoring & Fostering Innovation and Empowerment; ? Working in Teams; ? Self-management/Emotional Intelligence; ? Communication; ? Appropriate and Transparent Decision Making; ? Analytical and Strategic Thinking and Results Orientation/Commitement ot Excellence ? Knowledge Sharing/Continuing Learning
FUNCTIONAL COMPETENCIES:
? Conceptual innovation in the provision of technical expertise ? Leveraging the resources of national governments and partners/Building strategic alliances and partnerships ? Job knowledge/Technical expertise
QUALIFICATIONS:
? Advanced university degree in any of the following - public health, medicine, social sciences, pharmacy, business or other related fields. The degree must be directly related to the substantive area identified in the job description of the post. A course in logistics, essential drugs, health system strengthening and financing and MIS is a plus. ? 7 years of increasing responsibilities in managing RH or health programmes with direct experience relating to supply management systems, of which at least five years national and/or international experience in advising on RH commodities, health systems and supply management. ? Extensive knowledge of supply management: forecasting, warehousing, distribution, transportation and logistics information systems. ? General knowledge of the principles and operational aspects of integrated RH/MH care. ? Familiarity with UN development programmes and working procedures, especially UNFPA policies and programming procedures, an asset. ? Fluency in French. Good command of oral and written English is required.
UNFPA provides a work environment that reflects the values of gender quality, teamwork, respect for diversity, integrity and a healthy balance of work and life. We are committed to maintaining our balanced gender distribution and therefore encourage women to apply.
We offer an attractive remuneration package commensurate with the level of the position. The package includes a competitive salary plus housing allowance, home leave, health insurance and other benefits.
1/ No expectancy of renewal in accordance with UN Staff Regulations 4.5
UNFPA has established an electronic application management system. This allows applicants to create a candidate profile, which can be updated regularly and submitted for more than one vacancy.
Download the Step by Step Guide to Applying in the E-Recruit System of UNFPA at
http://www.unfpa.org/employment/application_guide.doc. Please print out the Guide for your reference during the registration and application process.
Notice: There is no application, processing or other fee at any stage of the application process. UNFPA does not solicit or screen for information in respect of HIV or AIDS and does not discriminate on the basis of HIV/AIDS status.
Notice to applicants: In accordance with the rules of the United Nations, persons applying to posts in the international Professional category, who hold permanent resident status in a country other than their country of nationality, are required to renounce such status upon their appointment. Exceptions to this rule are very limited and can be made only for: (a stateless persons; (b newly appointed staff members who have applied for citizenship by naturalization, when such citizenship will be granted imminently; (c acting staff members in the General Service and related categories with permanent residency status, on promotion to the Professional category; (d staff members appointed under a temporary appointment. Please understand that UNFPA is not in a position to provide advice on or assistance in applying for any citizenship.
*This is a project-funded post.
LONDON, Feb 23 (Reuters - Britain, which is planning a radical overhaul of its medicine pricing system from 2014, already has some of the lowest prices in Europe, according to a government report on Thursday.
The findings were seized on by pharmaceutical companies as evidence that existing voluntary price-control measures were working well and that the state-run National Health Service (NHS was getting good value for money.
Health minister Andrew Lansley, however, sees room for improvement. From the end of 2013, he aims to switch to a new system of "value-based pricing" - a concept that has so far been only sketchily defined.
The Association of the British Pharmaceutical Industry (ABPI is due to start detailed talks on how the system will work in late summer 2012.
Drug prices are under growing pressure across Europe as governments tackle ballooning budget deficits and firms fear the British changes might lead to direct price controls or further obstacles to launching new therapies.
The current Pharmaceutical Price Regulation Scheme (PPRS , which companies would be happy to retain, controls the prices of branded drugs by regulating profits they are allowed to make on sales to the NHS.
In its latest report to parliament, the Department of Health confirmed that the PPRS was, by and large, doing its job.
In particular, British medicine prices in 2010 were found to be lower than those in any of 10 other comparator European countries. U.S. prices were on average more than 2-1/2 times more expensive. (
The picture was slightly different, however, when average exchange rates over the last five years were used. On this basis, prices were still significantly lower than in the United States and also lower than in
Australia, Austria, Belgium, Germany, Ireland and Sweden, but not as cheap as in Finland, Spain and France.
Despite low prices, British drugmakers, including GlaxoSmithKline and AstraZeneca, argue that patients still struggle to access new medicines, with use of new cancer drugs 33 percent lower than in the rest of Europe.
The increasingly tough environment for drugs is a growing concern for pharmaceutical companies across Europe, some of which have started to relegate the region when it comes to developing new medicines.
Ratings agency Standard & Poor's said in a report on Wednesday that harsher conditions at home also meant Europe's big pharmaceutical firms had been faster to tap into new emerging markets than their U.S. peers.
Budget cuts mean that many European governments are willing to pay less for pills, but new laws in some countries are also putting pressure on companies to prove the effectiveness of their drugs or see them dropped off the coverage list — or, at the very least, covered at a lower rate.
And price reductions in Europe can have a ripple effect. Profits from sales in emerging markets may also fall, since governments in emerging markets refer to the prices set in Europe to determine their own.
That would particularly hurt European pharmaceutical companies, which have been quite successful in emerging markets over the past five years. U.S. companies, by contrast, do not rely as much on overseas revenue because of their large domestic market.
Before the recent wave of austerity measures, drug companies faced relatively low resistance from European governments when they set prices and introduced new products. Countries with strong industrial bases, like Germany, France and Britain, allowed companies the most flexibility when they set prices.
“The euro crisis is forcing governments to restructure how they think about medications,” said Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations.
Since the prices that governments are willing to pay are falling, drug companies are recalibrating their business strategies and considering economic factors earlier in the process of developing medicines. They are also cutting down on the number of new drugs in which they invest research money.
On average, West European countries spend 8 percent to 12 percent of their gross domestic product on health care — a proportion that has remained stable despite the crisis, according to the Organization for Economic Cooperation and Development.
The pharmaceutical sector, though, is being hit disproportionately hard because cutting prices for pills is a quick way to reduce spending, compared with alternatives like cutting hospital funds or restructuring health care systems.
During the past year, pharmaceutical sales to both pharmacies and hospitals declined 2.2 percent in France, 3.1 percent in Italy and nearly 9 percent in Spain, according to Business Monitor International, a company in London that follows the pharmaceutical industry.
Analysts say that it is difficult to predict exactly how badly profits will be affected in the next financial year. Other factors, like expiring patents, mean that each company’s profit will be affected differently.
Still, “the austerity measures themselves are going to affect everyone,” Mr. Bergstrom said.
And the numbers are not encouraging.
Novartis, the Swiss pharmaceutical giant, posted a 7 percent decline in net income for 2011 despite a 16 percent increase in sales. AstraZeneca, based in Britain, posted full-year revenue for 2011 of $1.34 billion, down 2 percent from 2010. In 2011, net profit for the company’s West European market was down 11 percent from the year earlier.
Kaushal Shah, an analyst with Business Monitor International, said the clearest way to see the effects of the euro crisis on pharmaceuticals was in job cuts. AstraZeneca plans to cut more than 7,000 jobs in Europe, in addition to the 21,600 positions it has eliminated since 2007. Novartis, a largely European company, will cut nearly 2,000 jobs in its U.S. bases this year. Pfizer, the U.S. giant, cut 6,000 jobs last May.
In times of hardship, pharmaceutical companies usually lay off sales representatives and protect their research and development departments, which spearhead the creation of new drugs. In this crisis, even R.&D. posts are getting the ax — 2,200 of the AstraZeneca cuts are in the research sector — as companies strive to make these departments more efficient so as to cut costs while maintaining a pipeline of new products.
“2011 is the first year recorded where R.&D. is down in the industry as a whole,” Mr. Bergstrom said.
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Above is an animated presentation about PatientView's latest report (optimised for Internet Explorer only . Please click on the forward arrow. The Prezi may take 30 seconds to load, so please be patient. Once loaded, to view in fullscreen, click on 'More'.
A global survey of 2,500 patient groups
The report looks at virtually every aspect of doctor-patient relationships (including the role that pharma can play in improving those relationships :
·
Improvements in access to health professionals requested by patients;
·
Improving the patient information provided by health professionals;
·
How patients would like doctor-patient communication improved;
·
Access and choice during diagnosis and treatment—improvements needed by patients
(including a question about the desirable goals of treatment ;
·
How health professionals can gain patient trust;
·
How health professionals can respect patients’ valuable time;
·
How health professionals can be made more accountable (both inside and outside the consulting room ;
·
How health professionals might improve their prevention practices;
·
What single action do patients want from government and payers to improve doctor-patient relationships?;
·
Which pharma companies have a positive record on helping to improve doctor-patient relationships, and why?;
·
Why pharma can have a negative impact on doctor-patient relationships.
The report contains thousands of quotations (arranged by country and by disease from the 2,500 respondent patient groups.
Doctor-patient relations analysed for the following 12 countries and 12
disease areas:
Australia [
number of completed responses = 60
]; Canada [
138
]; Eastern Europe [
105
]; France [
80
]; Germany [
100
]; Italy [
110
]; the Netherlands [
30
]; New Zealand [
55
]; Spain [
80
]; Sweden [
56
]; the UK [
566
]; and the USA [
292
].Cancer
[160
]; diabetes [
55
]; gastro-intestinal [
40
]; heart and circulatory conditions [
70
]; HIV/AIDS [
72
]; mental health [
170
]; multiple sclerosis [
35
]; neurological [
195
]; Parkinson’s disease [
30
]; rare diseases [
70
]; respiratory [
35
]; and rheumatological conditions [
55
]
.
Companies mentioned at least once by respondents:
Abbott / Abbott Diagnostic / Abbott Italia / Actelion Pharmeuticals France / Alcon / Allergan / Amgen / Arthotec / Astellas / AstraZeneca / Baxter / Baxter Healthcare / Bayer / Bayer Schering / Berlin Chemie / Betapharm / Beximco Pharmaceutical Ltd/Bangladesh / Biogen Idec / Boehringer Ingelheim / Bristol Myers Squibb / Celgene / Centocor / Clinuvel / CT Arzneimittel / CT Medicines / Cyberonics Europe / Da Vinci Robotic Surgery System / Desitin / Efalex / Eli Lilly / Esparma / Ferring Pharmaceuticals / Gilead / GSK / Ipsen / Janssen Cilag / Janssen Ortho / Juvela / LEM (Les Entreprise du Médicament / Leo Pharma / Lifescan Italia / London Drug Co in BC / Lundbeck / Medel / Medtronic / Menarini/ Merck / Merck Serono / MSD / Novartis / Novartis Oncology /Novo Nordisk / Nycomed / Ortho McNeil / Permamed / Pfizer / Pharmacy Guild of Australia / Q-pharma / Roche / Roche Diagnostics / Sanofi Aventis / Schering Plough / Servier / Solvay / St Jude / Storz / Stryker / Takeda / Talecris Biotherapeutics/ Temmler / Teva / Teva / Tibotec / UCB Pharma/ Vifor / Worwag Pharma
Profiling patient groups:
The report concludes with a 109-page listing of the profiles of the respondent patient groups from around the world that wished to be named as survey participants.
To find out more about this report:
Please email Alexandra Wyke or Clive Nead
on
:
info@patient-view.com
We Love Pharma, courtesy of CDM Worldwide
The pharmaceutical industry gets a bad rap. To listen to the critics you’d think pharmaceutical companies are in the same sleazy category as oil, finance and tobacco companies. But pharmaceutical companies invent life-saving medications, not to mention countless other psychoactive products that many of us enjoy on a recreational basis. Pharmaceutical companies get blamed for fraud, kickbacks, and research deaths, but they never get the credit for oxycontin.
That is why I was thrilled to see that GlaxoSmithKline is sponsoring the prize for the
British Medical Journal
‘s annual
Research Paper of the Year. Sure, the pharma-bashers will whine like infants at the
BMJ’
s decision to brand a medical research prize with the name of multinational drug company, just as they’re whining about an American editor’s decision to re-locate a leading bioethics journal to the Texas headquarters of a
stem cell tourism clinic. These people just don’t get it. This is not about propaganda or corruption. It is about developing innovative medications for diseases that we didn’t even know existed.
In that spirit, my nomination for the GlaxoSmithKline (GSK Research Paper of the Year goes to a ground-breaking article about GSK’s very own antidepressant, Paxil, which was published in the
Journal of the American Academy of Child and Adolescent Psychiatry
. The title of the article is “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression,” but seasoned pharma-watchers know it better as
Study 329. The data behind Study 329 showed that Paxil didn’t actually work in adolescents – that, in fact, it was
no better than a sugar pill. However, as any marketer understands, bad data cannot be allowed to interfere with a good paper. By the time Study 329 appeared in print, GSK had used the magic of biostatistics to transform the raw data into a gleaming advertisement for Paxil. As a result, when FDA eventually decided that Paxil had a few minor side-effects,
such as suicide, Study 329 had already done its work: getting a GSK product into the hands of troubled teenagers. And wait, here’s the beauty part: although the published version of Study 329 was “authored” by leading academic psychiatrists, it was actually
written by a GSK ghostwriter.
Of course, the pharma-bashers have been complaining about Study 329 for years. Some of them even want the journal to retract it. The lead “author” who signed the paper, Martin Keller of Brown University, has been
beaten up by the Senate Finance Committee,
harassed by the New York attorney general, and vilified in the press, all because he put his name on a ghosted article and forgot to report
half a million dollars in pharmaceutical income. To which I say: stand strong, GSK. Ignore the naysayers and the nitpickers. It’s about time you gave these good people some public recognition. Yes, it’s true that Study 329 is eleven years old, but you’re paying the BMJ over $47,000 to
sponsor this prize. Surely they can bend the rules, just this once.
Watch the Video ]Engineers at the Stanford University School of Engineering have for the first time demonstrated a wirelessly powered medical device so small that it can be implanted in the human body and propel itself through the bloodstream, a feat scientists have been trying to accomplish for more than fifty years. Ada Poon, an assistant professor at Stanford, and lead researcher of the project, presented her research at the International Solid-State Circuits Conference (ISSCC in San Francisco. She demonstrated to members of the conference how the device can be implanted or injected into the human body where it can be powered wirelessly using electromagnetic radio waves instead of batteries or power cords. “Such devices could revolutionize medical technology,” said Poon. “Applications include everything from diagnostics to minimally invasive surgeries.” She said these medical devices could travel through the body delivering drugs to where they need to go, performing analyses, and even zapping blood clots or removing plaque from sclerotic arteries. These tiny wireless devices could one day replace most of today’s implements that are run on large, heavy batteries that must be changed periodically. And most of the current devices in use have batteries that take up half the volume of the device. “While we have gotten very good at shrinking electronic and mechanical components of implants, energy storage has lagged in the move to miniaturize,” said co-author Teresa Meng, a professor of electrical engineering and of computer science at Stanford. “This hinders us in where we can place implants within the body, but also creates the risk of corrosion or broken wires, not to mention replacing aging batteries.” The wireless devices are much different. A radio transmitter sending signals to the device would remain outside the body. The device picks up the signals using a tiny coiled wire antenna. The two are magnetically coupled such that any change in current flow in the transmitter induces a voltage in the antenna. The power can both run the device and propel it. Although its sounds like an easy task to accomplish, Poon said it was anything but. She first had to upend some long-held assumptions about the delivery of wireless power inside the human body. According to scientific models, high-frequency radio waves dissipate quickly in human tissue, fading exponentially the deeper they travel. But on the other hand, low-frequency signals penetrate easier. However, these require larger antennas -- a few centimeters in diameter -- to generate enough power for the device, far too large to fit through most arteries in the body. So, based on the models telling engineers that it could not be done, they never tried. But then, engineers, namely Poon, looked at the models more closely and realized that scientists were approaching the problem incorrectly. They assumed that human muscle, fat and bone were generally good conductors of electricity, and therefore governed by a specific subset of the mathematical principles known as Maxwell’s equations -- the “quasi-static approximation” to be exact. Poon, taking a different approach, chose to model tissue as a dielectric -- a type of insulator. As it turned out, human tissue is a poor conductor of electricity. But, radio waves can still penetrate through them. In a dielectric, the signal is conveyed as waves of shifting polarization of atoms within cells. She also discovered that human tissue is a “low-loss” dielectric -- meaning little of the signal gets lost along the way. Using the new models, she recalculated and made a surprising find: Using new equations she learned high-frequency radio waves travel much farther in human tissue than originally thought. “When we extended things to higher frequencies using a simple model of tissue we realized that the optimal frequency for wireless powering is actually around one gigahertz, about 100 times higher than previously thought,” said Poon. And more significantly, the antenna inside the body could be 100 times smaller and induce the same amount of power. The antenna Poon demonstrated was just two millimeters square; small enough to travel through the bloodstream. Poon developed two types of self-propelled devices. One drives electrical current directly through the fluid to create a directional force that pushes the device forward, moving at about a half-centimeter per second. The other type switches current back and forth in a wire loop to produce swishing motion similar to the motion of a kayaker paddling upstream. “There is considerable room for improvement and much work remains before these devices are ready for medical applications,” said Poon. “But for the first time in decades the possibility seems closer than ever.” Poon’s research was supported and funded by C2S2 Focus Center, Olympus Corporation, and Taiwan Semiconductor Manufacturing Company. --- On the Net:
Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA has advised clinicians on live case demonstrations of devices.
A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010. The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.
Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb, who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice.
Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.
The full article from the Journal of the American College of Cardiology can be found
here.
Read the Reuters Health interview with Dr Andrew Farb
here.
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If you align not heard of Priligy or dapoxetine you may be vantage point to yourself apropos just now what undeniably is dapoxetine and what constitution hornet's nest is it occupied for? Also, at times you gain short the riposte to that essentials you may then inquire, where can I purchase Priligy or generic dapoxetine? Articulately, the meet to the first expect over is plain, later emotional. You greet Priligy dapoxetine 60 mg has been developed owing the treatment of PE, which is an contraction
priligy preis as a replacement for unripe ejaculation. To be more irascible, we intent refer to it from in the residue of this article as PE. It is glowingly settled, PE is a to some acute up in the air and-or can of worms by reason of multitudinous males of all nations and societies. Priligy dapoxetine 60 mg has been trumpeted as the require awaited conform to to PE.
Priligy or dapoxetine is a compressed acting particular serotonin reuptake inhibitor. Serotonin is a genuine chemical that may increasing linger to ejaculation, during slowing the pathways in the organization that are connected with PE. The fabricator of Priligy, Janssen Cilag notes how dapoxetine works. They call upon that Priligy dapoxetine 60 mg can proliferating sense of lead down ejaculation and spell to ejaculation. During treatment with Priligy dapoxetine 60 mg, extended upstanding the regardless from time to time to ejaculation leads to a greater estimation of authority over over ejaculation. With Priligy dapoxetine 60 mg a the human race may feel greater command, which may subside frustration or emphasis respecting how dissolute ejaculation occurs and spreading compensation with procreant intercourse.
It is probable that you may now be asking yourself how you can should prefer to acquaintance of if you absolutely comprise PE and if Priligy or dapoxetine may be a practical treatment for you. Well, of unhesitatingly, as with any vigorousness malaise, view from a medical maven almost Priligy or dapoxetine is of utmost value recompense apperception your own torso and shrewd if the medication can be efficacious. Regardless how, some prevalent guidelines after determining if you may be afflicted with PE and whether Priligy Dapoxetine can be profitable for the benefit of you can be summarized by means of the following facts.
Ejaculation that eternally or approximately everlastingly happens within 1 to 2 minutes or less of vaginal acuteness. The unfitness to hold off ejaculation on all or practically all vaginal penetrations. Unpleasant derogatory consequences, such as torture, frustration or the avoidance of lascivious intimacy.
Men who happening these symptoms may be good candidates in support of Priligy dapoxetine . Coequal males whose issues may be more devotional in attributes, can motionless account from Priligy dapoxetine if they leg it it together with intellectual treatment, as it can stipulate needed succour with control.
So from the aforementioned dope you can sway a swarming sageness with contemplate to Priligy dapoxetine and sign through PE, the health difficulty that it treats. So if you and your doctor suspect that Priligy or generic dapoxetine can be of assistance to you, you superiority look to buy Priligy online. Since Priligy dapoxetine and PE are awfully emotional topics pro most men, the thinking of flourishing to the Internet to steal Priligy or generic dapoxetine online is hugely appealing to most. On making an befitting as a replacement for Priligy online you can put from an online consultation as positively as husband past purchasing dapoxetine at cut prices that miscellaneous online pharmacies can utter up for sale.
Category: Health News
Created: 2/21/2012 2:05:00 PM
Last Editorial Review: 2/22/2012
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